[Federal Register Volume 66, Number 63 (Monday, April 2, 2001)]
[Notices]
[Pages 17564-17565]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-8058]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99D-4130]


Medical Devices; Information Disclosure by Manufacturers to 
Assemblers for Diagnostic X-Ray Systems; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; availability of guidance.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a final guidance entitled ``Information Disclosure by 
Manufacturers to Assemblers for Diagnostic X-Ray Systems; Final 
Guidance for Industry and FDA.'' This guidance document is intended to 
provide guidance to the industry about meeting requirements for 
disclosure to assemblers, and to others upon request, of certain types 
of information at a cost not to exceed the cost of publication and 
distribution to ensure that x-ray systems will meet Federal performance 
standards.

DATES: Submit written comments on agency guidances at any time.

ADDRESSES: Submit written requests for single copies on a 3.5'' 
diskette of the guidance document entitled ``Information Disclosure by 
Manufacturers to Assemblers for Diagnostic X-Ray Systems; Final 
Guidance for Industry and FDA'' to the Division of Small Manufacturers 
Assistance (HFZ-220), Center for Devices and Radiological Health, Food 
and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send 
two self-addressed adhesive labels to assist that office in processing 
your request, or fax your request to 301-443-8818. See the 
SUPPLEMENTARY INFORMATION section for information on electronic access 
to the guidance.
    Submit written comments concerning the guidance to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Thomas M. Jakub, Center for Devices 
and Radiological Health (HFZ-322), Food and Drug Administration, 2094 
Gaither Rd., Rockville, MD 20850, 301-594-4591.

SUPPLEMENTARY INFORMATION:

I. Background

    This final Level 1 guidance document entitled ``Information 
Disclosure by Manufacturers to Assemblers for Diagnostic X-Ray Systems; 
Final Guidance for Industry and FDA'' is intended to provide guidance 
to diagnostic x-ray system manufacturers, users, assemblers, and others 
concerning the requirement to disclose information about the assembly, 
installation, adjustment, and testing (AIAT) of x-ray components for 
diagnostic x-ray systems. (See Sec. 1020.30(g) (21 CFR 1020.30(g))). 
With the advancement of technology and the use of computers with 
corresponding software, manufacturers need clarification about what 
information must be disclosed to satisfy the requirements of AIAT 
disclosure. This final Level 1 guidance document supersedes the 
corresponding draft guidance entitled ``Draft Guidance on Information 
Disclosure by Manufacturers to Assemblers for Diagnostic X-Ray 
Systems,'' which was announced in the Federal Register on October 8, 
1999 (64 FR 54901). The comment period closed on January 6, 2000. The 
agency received several comments and recommendations concerning the 
draft guidance. A number of comments received by the agency addressed 
issues that do not fall within the scope of the guidance and 
Sec. 1020.30(g). The final guidance contains only minor changes from 
the draft guidance.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115; 65 FR 56468, September 19, 2000). 
This guidance document represents the agency's current thinking on 
information disclosure by manufacturers to assemblers for diagnostic x-
ray systems, as required by Sec. 1020.30(g). It does not create or 
confer any rights for or on any person and does not operate to bind FDA 
or the public. An alternative approach may be used if such approach 
satisfies the requirement of the applicable statutes and regulations.

III. Electronic Access

    In order to receive ``Guidance on Information Disclosure by 
Manufacturers to Assemblers for Diagnostic X-Ray Systems; Final 
Guidance for Industry and FDA'' via your fax machine, call the CDRH 
Facts-On-Demand system at 800-899-0381 or 301-827-0111 from a touch-
tone telephone. At the first voice prompt press 1 to access DSMA Facts, 
at the second voice prompt press 2, and then enter the document number 
(2619) followed by the pound sign (#). Then follow the remaining voice 
prompts to complete your request.
    Persons interested in obtaining a copy of the guidance may also do 
so using the Internet. CDRH maintains an entry on the Internet for easy 
access to information including text, graphics, and files that may be 
downloaded to a personal computer with access to the Internet. Updated 
on a regular basis, the CDRH home page includes ``Guidance on 
Information Disclosure by Manufacturers to Assemblers for Diagnostic X-
Ray Systems; Final Guidance for Industry and FDA,'' device safety 
alerts, Federal Register reprints, information on premarket submissions 
(including lists of approved applications and manufacturers' 
addresses), small manufacturers' assistance, information on video 
conferencing and electronic submissions, mammography matters, and other 
device-oriented information. The CDRH home page may be accessed at 
http://www.fda.gov/cdrh. ``Guidance on Information Disclosure by 
Manufacturers to Assemblers for Diagnostic X-Ray Systems; Final 
Guidance for Industry and FDA'' is also available at http://www.fda.gov/cdrh/comp/2619.html. Guidance documents are also available 
on the Dockets Management Branch website at http://www.fda.gov/ohrms/dockets/default.htm.

IV. Comments

    Interested persons may, at any time, submit written comments 
regarding the guidance to the Dockets Management

[[Page 17565]]

Branch (address above). Two copies of any comments are to be submitted, 
except that individuals may submit one copy. Comments are to be 
identified with the docket number found in brackets in the heading of 
this document. The guidance and received comments are available for 
public examination in the Dockets Management Branch between 9 a.m. and 
4 p.m., Monday through Friday.

    Dated: March 26, 2001.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 01-8058 Filed 3-28-01; 3:43 pm]
BILLING CODE 4160-01-S